Iminox

Iminox Indications/Uses

imatinib

Manufacturer:

Idaman Pharma

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Indications/Uses
Imatinib is indicated for the treatment of: Adult and pediatric patients with newly diagnosed chronic myeloid leukemia (CML) as well as for the treatment of adult and pediatric patients with CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Adjuvant treatment of adult patients following resection of GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.
Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with F1P1L1-PDGFRα rearrangement.
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ALL, MDS/MPD, on haematological response rates in HES/CEL and ASM and on objective response rates in GIST and DFSP, and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene rearrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival in diseases.
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